Correlation of Peak Tidal Inspiratory Flow Measured Before and After Extubation in Adult Patients With Hypoxemia

August 8, 2023 updated by: Rush University Medical Center

Correlation of Peak Tidal Inspiratory Flow Measured Before and After Extubation in Adult Patients With Hypoxemia, and Patients' Responses to Different Flows Above Their Peak Tidal Inspiratory Flow During High Flow Nasal Cannula Therapy

In this study, patients who are ready for extubation and indicated for high-flow nasal cannula therapy after extubation will be enrolled, the investigators would measure the patient peak tidal inspiratory flow (PTIF) pre and post extubation to explore the correlation between the two PTIFs. Moreover, different HFNC flows would be applied, to explore the patient response in terms of oxygenation and lung aeration to different flow ratios that matched and are above post-extubation PTIF.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

High-flow nasal cannula (HFNC) oxygen therapy has been shown to improve oxygenation, reduce the need for intubation for patients with acute hypoxemic respiratory failure (AHRF) and avoid reintubation for post-extubation patients who had high-risk factors. HFNC refers to the delivery of gas at flows that exceed the patient peak inspiratory flow during tidal breathing, However, patient peak tidal inspiratory flow (PTIF) is found to vary greatly among different patients, from 20 to 50 L/min, making it difficult to properly set HFNC in a way to achieve the desired effects. In two recently published studies in intubated patients, PTIF varied from 25-65 L/min or 40-80 L/min, thus this study aims to investigate the correlation between pre-extubation PTIF in different modalities of SBT and post-extubation PTIF for adult patients, who are indicated to use HFNC immediately after extubation. In addition, the investigators aim to explore the patient response in terms of oxygenation and lung aeration to different flow ratios that matched and are above post-extubation PTIF.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult intubated patients aged between 18 to 90 years
  • Pass spontaneous breathing trial and receive the order to be extubated
  • Have at least one of the indications to use HFNC after extubation

Exclusion Criteria:

  • Need to use inhaled epoprostenol via HFNC
  • Pregnant
  • Unable to use resuscitation mask, such as facial trauma, claustrophobia
  • Non-English speaker
  • Inability to verbally communicate
  • Using extracorporeal membrane oxygenation (ECMO)
  • Hemodynamically unstable
  • Difficult airway

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HFNC flow set at patient peak tidal inspiratory flow
HFNC flow will be set at the level that matches patient peak tidal inspiratory flow
Other: HFNC flow set at patient peak tidal inspiratory flow
HFNC flow will be set at the level equal to patient peak tidal inspiratory flow
Experimental: HFNC flow set at 1.33 times of patient peak tidal inspiratory flow
HFNC flow will be set at the level that is 1.33 times of patient peak tidal inspiratory flow
Other: HFNC flow set at 1.33 times of patient peak tidal inspiratory flow
HFNC flow will be set at 1.33 times of patient peak tidal inspiratory flow
Experimental: HFNC flow set at 1.67 times of patient peak tidal inspiratory flow
HFNC flow will be set at the level that is 1.67 times of patient peak tidal inspiratory flow
Other: HFNC flow set at 1.67 times of patient peak tidal inspiratory flow
HFNC flow will be set at 1.67 times of patient peak tidal inspiratory flow
Experimental: HFNC flow set at 2 times of patient peak tidal inspiratory flow
HFNC flow will be set at the level that is 2 times of patient peak tidal inspiratory flow
Other: HFNC flow set at 2 times of patient peak tidal inspiratory flow
HFNC flow will be set 2 times of patient peak tidal inspiratory flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SpO2/FIO2
Time Frame: 20 minutes after each flow setting
Twenty mins after each flow setting, pulse oximetry divided by fraction of inspired oxygen will be used to assess patient's oxygenation response to different flow
20 minutes after each flow setting

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
End-expiratory lung volume assessed by EIT
Time Frame: 20 minutes after each flow setting
Twenty mins after each flow setting, electrical impedance tomography (EIT) will be used to assess patient's end -expiratory lung volume 20 mins after each flow setting
20 minutes after each flow setting
self-evaluated comfort
Time Frame: 20 minutes after each flow setting
Twenty mins after each flow setting, patient comfort will be assessed using a visual numerical scale with a score of 0 as the worst and 10 as the best comfort
20 minutes after each flow setting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Collaborators

Hospital Vall d'Hebron

Investigators

  • Principal Investigator: JIE LI, PhD, Rush University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2022

Primary Completion (Actual)

August 8, 2023

Study Completion (Actual)

August 8, 2023

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFNC-Flow-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified patient data will be shared upon reasonable request 3 months after publication.

IPD Sharing Time Frame

3 months after the study is published

IPD Sharing Access Criteria

the investigators need to send their IRB approved research protocol to Jie_li@rush.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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